INTERMEDIATE-SIZE PATIENT POPULATIONS EXPANDED ACCESS TO TREATMENT FOR SARCOPENIC OBESITY (NCT06784297) | Clinical Trial Compass
TEMPORARILY_NOT_AVAILABLENot Applicable
INTERMEDIATE-SIZE PATIENT POPULATIONS EXPANDED ACCESS TO TREATMENT FOR SARCOPENIC OBESITY
Plain-language summary
The expanded access is designed for patients requesting the treatment, and whose medical condition may benefit from treatment, but are unable to participate in any other IMM01-STEM clinical trial in their physician's opinion for reasons that include: (1) They do not meet enrollment criteria, or (2) They cannot perform the assessment of outcomes, or (3) The trial site is not geographically accessible.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Sex: male or post-menopausal female (as defined by the absence of a period for at least 12 consecutive months)
. Race/nationality: all races and ethnicities accepted for which there are validated reference values for obesity and sarcopenia diagnostic criteria
. Disease characteristics: to be eligible, the participant must meet one criterion for obesity and at least one criterion for sarcopenia, as defined below:
. Abdominal obesity defined by a waist circumference ≥ 40 inches (102 cm) for men, ≥ 35 inches (88 cm) for women (American Heart Association)
. Abdominal obesity as a waist-to-hip ratio of at least 0.90 in men and 0.85 or more for
. No obesity, normal BMI women (World Health Organization)
Exclusion criteria
. Qualifying individuals by the current enrollment criteria that are in a 50-mile geographical radius of any IMM01-STEM clinical trial site or a potential clinical site.
. Inability to sign an informed consent
. Concomitant investigational drugs and treatments
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.